MAUDE Adverse Event Report: MEDTRONIC, INC. LAUNCHER; CATHETER, PERCUTANEOUS

Model Number	LA6JR40
Health Effect - Clinical Code	Myocardial Infarction (1969)
Date of Event	07/26/2019
Type of Reportable Event	Malfunction
Event or Problem Description
A jr4 catheter was used to engaged the right coronary artery for a stent placement.The site was predilate, stented and post dilated without complication.During post angiogram of the right coronary artery, bubbles were sent down the vessel.St elevation was noted on the ekg.Slow flow was noted in the vessel.Intracoronary nitroprusside was administered.Patient was started on a levophed drip.St elevation resolve with ic nipride.A kink/hole was noted on the catheter by the physician.The physician concluded that the kink/hole on the catheter could of cause the bubbles.Spoke with cardiac catheter lab clinical manager.During catheterization, the proceduralist was attempting to manipulate the catheter guide in a normal fashion to maintain access.During this manipulation, the line was thought to have become kinked which led to the above incident.After needed interventions, the patient had a favorable outcome.Patient remains in house for observation purposes.

• Brand Name: LAUNCHER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC.; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8905820
• Report Number: 8905820
• Device Sequence Number: 2548520
• Product Code: DQY
• UDI-Device Identifier: 00613994817778
• UDI-Public: (01)00613994817778
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/29/2019
• Report Date (Section F): 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: LA6JR40
• Device Lot Number: 0009768419
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 77
• Date Report Sent to FDA: 07/29/2019